FDA Shuts the Door on NDAs

By Mari SerebrovWashington Editor

Don’t bother to submit new drug and supplemental applications (NDAs) during the government shutdown, the FDA is telling drugmakers.

With 55 percent of its work force still on the job despite the shutdown, the agency said it will continue reviewing applications that were submitted prior to fiscal 2014, so long as those activities are covered by carryover user fee balances. But until Congress authorizes the agency’s 2014 spending levels, the FDA claimed it doesn’t have the authority to accept user fees for the new fiscal year that began Tuesday.

The agency also determined that, without a spending bill in place, it can’t touch 2014 user fees already paid under the early collection authorization. As a result, the FDA will not review applications that have been submitted with fiscal 2014 fees, even if they were received before Tuesday and the beginning of the shutdown – which the agency refers to as “the lapse in appropriations.”

The big question Wednesday was how long the “lapse” would continue. As both the House and Senate continued their finger-pointing, speculation that the shutdown could be extended into a debate over raising the debt ceiling didn’t seem so speculative.

While the government hit the current debt ceiling of nearly $16.4 trillion in May, the Treasury has used “extraordinary” measures to avoid exceeding it, according to the Congressional Budget Office. But the Treasury will run out of ways to do that within a few weeks. If the ceiling isn’t raised by then, the government would have to default on its payments for the first time.

The House spent much of the day Wednesday working on a piecemeal spending approach that would allow certain government agencies, including the National Institutes of Health, to return to business as usual.

That approach didn’t fly with the Senate, where Majority Leader Harry Reid (D-Nev.) continued to push for a clean continuing resolution – that is, one without amendments dealing with other matters. He promised that once the government is running again, the Senate would negotiate with the House to resolve some of the partisan issues, including fixes to the controversial Affordable Care Act.

The president scheduled a meeting for late Wednesday afternoon with Senate and House leadership in hopes of ending the shutdown. White House Press Secretary Jay Carney insisted it would not be a negotiating session. Instead, he said, the president would impress on the leadership the importance of reopening the government and ensuring there’s not even the threat of a default on the nation’s debt.

If Congress agrees to reopen government this week, the short shutdown shouldn’t have much impact on the filing of NDAs. However, submission delays caused by a longer lapse could lengthen the time to approval. “This has significant implications for human drug review activities,” said Matthew Bennett, senior vice president of the Pharmaceutical Research and Manufacturers of America (PhRMA).

Because of the implications for drugmakers and the potential impact on patients, PhRMA is working with “the FDA, the administration and Congress to advocate for the agency’s ability to access user fees and to carry out its critical public health mission,” Bennett added.

Even if the agency could use its 2014 user fees, it would still be somewhat limited in its review of applications, as only two-thirds of the review process is funded by the fees. The other third comes from tax dollars. (See BioWorld Today, Oct. 2, 2013.)

As part of the review process of pre-2014 applications, the FDA said it will continue to hold advisory committee meetings. But, as it generally does, it advised interested parties to watch the adcom calendar for cancellations.

Meanwhile, Congress is indefinitely postponing several government oversight hearings, presumably because agency staff isn’t available to testify or gather the necessary documents. One of the postponed hearings, originally set for Thursday morning, was on the implementation of the FDA Safety and Innovation Act, the fifth rendition of PDUFA fees, that was passed last year. (See BioWorld Today, June 27, 2012.)

Janet Woodcock and Jeffrey Shuren, directors of the FDA’s drug and device centers, respectively, were supposed to testify at that hearing before the House Energy and Commerce Subcommittee on Health.

The impasse between the House and the Senate over a continuing resolution that would fund the government for another month or two in lieu of a 2014 budget hasn’t delayed work on other matters.

The House passed the Drug Quality and Security Act, H.R. 3204, Saturday as it gathered to vote on the continuing resolution. The bipartisan bill, which would increase the FDA’s authority over large compounding pharmacies and develop a tracking system for prescription drugs, has the support of the leadership of the Senate Health, Education, Labor and Pensions Committee, but the full Senate has yet to consider it. (See BioWorld Today, Sept. 27, 2013.)

The Senate Foreign Affairs Committee did send S. 1545 to the Senate floor this week in a bipartisan effort to renew authorization and funding for the President’s Emergency Plan for AIDS Relief (PEPFAR). The popular program, which has helped with HIV/AIDS relief throughout the world, expired Monday. A companion bill, H.R. 3177, was introduced in the House last week. (See BioWorld Today, Sept. 26, 2013.)

Other Regulatory News

• An inverted black triangle began to appear on some drug labeling this week in the European Union (EU) as part of the European Medicines Agency’s effort to increase adverse event reporting for specific drugs. Beginning this month, the triangle, accompanied by the words “This medicinal product is subject to additional monitoring,” is to appear on all biologics, as well as drugs that contain an active substance authorized in the EU after Jan. 1, 2011, that require postmarket studies or that were given conditional approval or authorized under exceptional circumstances.

• The U.S. Supreme Court agreed Tuesday to hear arguments in Highmark Inc. v. Allcare Management Systems Inc., a case involving patent trolls. On appeal from the U.S. Court of Appeals for the Federal Circuit, Highmark asks whether a district court is entitled to deference when it awards attorney’s fees in patent infringement suits brought by a patent troll, based on its judgment that the suit is “objectively baseless.”